450 mg film-coated tablets
valganciclovir
What Valganciclovir Bluefish is and what is it used for
Valganciclovir Bluefish belongs to a group of drugs that act directly to prevent the multiplication of viruses. The active ingredient in the tablets, valganciclovir, is converted in the body to ganciclovir. Ganciclovir prevents a virus called cytomegalovirus ( CMV ) from multiplying and attacking healthy cells. In patients with a weakened immune system, CMV can cause infection in the body’s organs. This can be life-threatening.
Valganciclovir Bluefish is used for:
- treatment of CMV infection in the eye’s retina in adult patients with acquired immunodeficiency syndrome ( AIDS ). CMV – infection of the retina of the eye can cause vision problems and even blindness.
- to prevent CMV infection in adults and children who are not infected with CMV and who have received an organ transplant from someone who was infected with CMV.
The valganciclovir contained in Valganciclovir Bluefish may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Valganciclovir Bluefish
Do not take Valganciclovir Bluefish:
- if you are allergic to valganciclovir, ganciclovir, or any of the other ingredients of this medicine (listed in section 6).
- if you are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valganciclovir Bluefish:
- if you are allergic to aciclovir, penciclovir, valaciclovir or famciclovir. These are other drugs used to treat viral infections.
Take special care with Valganciclovir Bluefish
- if you have too few white blood cells, red blood cells, or platelets (small cells involved in blood clotting ) in your blood. Your doctor will carry out blood tests before you start taking Valganciclovir Bluefish tablets and more tests will be done while you are using the tablets.
- if you are undergoing radiation therapy or hemodialysis
- if you have kidney problems. Your doctor may need to prescribe you a lower dose and your blood levels may need to be checked frequently during treatment.
- if you are currently taking ganciclovir capsules and your doctor wants you to switch to Valganciclovir Bluefish tablets. You mustn’t take more tablets than you are prescribed by your doctor, otherwise, there is a risk of overdose.
Other medicines and Valganciclovir Bluefish
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
If you take other medicines at the same time as Valganciclovir Bluefish, the combination may affect the amount of medicine absorbed into your blood or possibly cause harmful effects. Tell your doctor if you are already taking medicines that contain any of the following:
- imipenem-cilastatin ( antibiotics ). May cause seizures if taken with Valganciclovir Bluefish
- zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine or similar medicines used to treat AIDS
- adefovir or other medicines used to treat hepatitis B
- probenecid (medicine for gout). The amount of ganciclovir in the blood may increase if probenecid and Valganciclovir Bluefish are taken at the same time
- mycophenolate mofetil, cyclosporin, or tacrolimus (used after transplantation)
- vincristine, vinblastine, doxorubicin, hydroxyurea, or similar anticancer drugs
- trimethoprim, combinations with trimethoprim/sulfa and dapsone ( antibiotics )
- pentamidine (medicine to treat parasites or lung infections)
- flucytosine or amphotericin B (antifungal).
Valganciclovir Bluefish with food and drink
Valganciclovir Bluefish should be taken with food. If for some reason you cannot eat, you should still take Valganciclovir Bluefish as usual.
Pregnancy, breastfeeding, and fertility
You should not take Valganciclovir Bluefish if you are pregnant unless your doctor advises you to do so. You must tell your doctor if you are pregnant or planning to become pregnant. Taking Valganciclovir Bluefish during pregnancy may harm your unborn baby.
You should not take Valganciclovir Bluefish if you are breastfeeding. If your doctor wants to start treatment with Valganciclovir Bluefish, you must stop breastfeeding before you start taking the tablets.
Women of childbearing potential must use effective contraception while being treated with Valganciclovir Bluefish and for at least 30 days after treatment ends.
Men whose partners may become pregnant should use a condom while being treated with Valganciclovir Bluefish and they should continue to use a condom for 90 days after stopping treatment.
Driving ability and use of machinery
Do not drive or use tools or machines if you feel dizzy, tired, shaky, or confused while taking this medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Ask your doctor or pharmacist for advice before taking any medicine.
Valganciclovir Bluefish contains allura red AC
Valganciclovir Bluefish contains Allura red AC which can induce an allergic reaction.
How to take Valganciclovir Bluefish
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
You must handle the tablets carefully. The tablets must not be split or crushed. You should swallow the tablets whole and they should, if possible, be taken with food. If you accidentally touch damaged tablets, wash your hands thoroughly with soap and water. If any powder from the tablets gets in your eyes, rinse your eyes with sterile water or clean water if sterile water is not available.
Never take more tablets than prescribed by your doctor to avoid overdose.
Valganciclovir Bluefish tablets should, if possible, be taken with food – see section 2.
Adults:
Prevention of CMV disease in organ transplant patients
You must start taking this medicine within 10 days of the transplant. The usual dose is two tablets taken ONCE daily. You should continue this dose until 100 days after the transplant. If you have received a kidney transplant, your doctor may advise you to take the tablets for 200 days.
Treatment of active CMV – infection in the retina of the eye in patients with AIDS (so-called induction treatment)
The usual dose is two tablets of Valganciclovir Bluefish taken TWICE daily for 21 days (three weeks). Do not take this dose for more than 21 days unless your doctor tells you to, as your risk of side effects may increase.
Long-term treatment to prevent recurrent active inflammation in AIDS patients with CMV infection in the retina of the eye (so-called maintenance treatment)
The usual dose is two tablets taken ONCE daily. You should try to take the tablets at the same time each day. Your doctor will tell you how long to continue taking Valganciclovir Bluefish. If your retinitis worsens while taking this dose, your doctor may ask you to repeat the induction treatment (as above) or decide to give you another medicine to treat CMV infection.
Elderly patients
Valganciclovir has not been studied in elderly patients.
Patients with kidney problems
If your kidneys are not fully functioning, your doctor may instruct you to take fewer tablets per day or to only take the tablets on certain days of the week. It is very important that you only take the number of tablets prescribed by your doctor.
Patients with liver problems
Valganciclovir Bluefish has not been studied in patients with liver problems.
Use for children and adolescents
Prevention of CMV disease in organ transplant patients
Children should start taking this medicine within 10 days of the transplant. The dose given varies depending on the size of the child and should be taken ONCE daily. Your doctor will decide on the most appropriate dose based on your child’s height, weight, and kidney function. You should continue with this dose up to 100 days after the transplant. If your child has received a kidney transplant, your doctor may advise you to take the medicine for 200 days.
For children who cannot swallow Valganciclovir Bluefish, the availability of other dosage forms can be checked, e.g. powder for oral solution.
If you have taken too much Valganciclovir Bluefish
If you have ingested, or think you have ingested too much medicine or if e.g. If a child has ingested the drug by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice. If you have taken too many tablets, you can have serious side effects, especially in the blood and kidneys can be affected. You may need hospital care.
If you forget to take Valganciclovir Bluefish
If you forget to take your tablets, take the missed dose as soon as you remember and take the next dose at the usual time. Do not take a double dose to make up for missed tablets.
If you stop taking Valganciclovir Bluefish
Do not stop taking this medicine unless your doctor tells you to.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
Up to 1 in 1,000 people may have a sudden and severe allergic reaction to valganciclovir (anaphylactic shock ). STOP taking Valganciclovir Bluefish and go to the emergency department of your nearest hospital if you experience any of the following:
- increasing itchy skin rash ( hives )
- sudden swelling of the throat, face, lips, and mouth which may cause difficulty swallowing and breathing
- sudden swelling of hands, feet, or ankles.
Serious side effects are
Tell your doctor immediately if you notice any of the following serious side effects – your doctor may ask you to stop taking the medicine and you may need emergency medical attention.
Very common: may affect more than 1 in 10 users
- low white blood cell count – with signs of infection such as sore throat, mouth sores, or fever
- low red blood cell count – signs are shortness of breath, tiredness, palpitations, or pale skin
Common: may affect up to 1 in 10 users
- blood poisoning ( sepsis ) – signs are fever, chills, palpitations, confusion, and slurred speech
- low platelet count – signs are bleeding or bruising more easily than usual, blood in the urine or feces, or bleeding from the gums where the bleeding may be severe
- very low blood cell count
- pancreatitis – signs are abdominal pain that spreads to the back
- convulsions
Uncommon: may affect up to 1 in 100 users
- failing blood cell production in the bone marrow a
- hallucinations – hearing or seeing things that are not real
- deviant thoughts or feelings, loss of contact with reality
- kidney failure
Side effects that occurred during treatment with valganciclovir or ganciclovir are reported below:
Other side effects ar
Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:
Very common: may affect more than 1 in 10 users
- cod and pollack
- upper respiratory tract infection (eg sinusitis, tonsillitis)
- loss of appetite
- headache
- cough
- shortness of breath
- diarrhea
- nausea or vomiting
- abdominal pain
- eczema
- fatigue
- fever
Common: may affect up to 1 in 10 users
- influenza
- urinary tract infection – signs are fever, need to urinate more often, pain when urinating
- infection of the skin or tissue under the skin
- mild allergic reaction – signs may be red, itchy skin
- weight loss
- feeling depressed, anxious, or confused
- sleep difficulties
- weakness or numbness in the hands or feet, which can affect balance
- altered sensation, tingling, prickling, itching, or burning sensation
- taste changes
- overindulge
- eye inflammation (conjunctivitis), eye pain, or vision problems
- earache
- low blood pressure, which can cause dizziness or lightheadedness
- swallowing difficulties
- constipation, flatulence, indigestion, abdominal pain, bloating
- mouth ulcers
- abnormal results in laboratory tests that measure liver and kidney function
- night sweats
- itching, rash
- hair loss
- back pain, muscle or joint pain, muscle contractions
- dizziness, weakness, or general malaise
Uncommon: may affect up to 1 in 100 users
- feel upset
- tremors, tremors
- deafness
- irregular pulse
- hives, dry skin
- blood in the urine
- male infertility – see the section on fertility
- chest pain
Separation of the inner part of the eye (retinal detachment) has only occurred in AIDS patients treated with valganciclovir for CMV infection.
Additional side effects in children and adolescents
Side effects reported in children and adolescents are similar to those reported in adults.
How to store Valganciclovir Bluefish
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the can after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is valganciclovir.
- Other ingredients are microcrystalline cellulose (Avicel PH191, PH102), crospovidone (Polyplasdone XL), stearic acid 50, and povidone (K-29/32). The film coating contains hypromellose, macrogol, titanium dioxide (E171), and Allura red AC aluminum lacquer (E129).
Appearance and package sizes of the medicine
Valganciclovir Bluefish tablets are pink oval tablets marked with “450” on one side and plain on the other side. The diameter of the tablet is 16.5 mm.
Manufacturer:
Eigen Pharma Ltd.,
Westside Business Park,
Old Kilmeaden Road,
Waterford,
Ireland
or
Millmount Healthcare
Block 7
City North Business Campus
Stamullen
Co. Meath
Ireland
This medicine is approved in the European Economic Area under the names:
| Germany | Valganciclovir Bluefish 450 mg film-coated tablet |
| Portugal | Valganciclovir Bluefish 450 mg comprimidos revestidos por película. |
| Sweden | Valganciclovir Bluefish 450 mg film-coated tablets |
| Austria | Valganciclovir Bluefish 450 mg film-coated tablet |